(181 days)
The Axle Interspinous Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1 inclusive). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Axle Interspinous Fusion System is intended for use with bone graft material, and not for stand-alone use.
The Axle Interspinous Fusion System consists of plates and inserts of various sizes that are used to provide supplemental stabilization of the spinous processes to support fusion. The system components can be assembled in a variety of configurations so that adaptations can be made to take into account pathology and individual patient anatomy. The implant components are provided clean and non-sterile.
The provided text describes a medical device, the "Axle™ Interspinous Fusion System," and its clearance by the FDA based on substantial equivalence to a predicate device. The information primarily focuses on the device's design, intended use, and biomechanical testing to demonstrate performance.
Here's an analysis of the provided information against your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Measured Performance) | Reported Device Performance |
|---|---|
| Mechanical Performance: |
- Static Compression Bending
- Static Torsion
- Fatigue Compression Bending | "Biomechanical testing results indicate that the Axle Interspinous Fusion System is substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use."
(Specific numerical values or thresholds for performance are not provided in this summary, but the claim is one of equivalence to the predicate device, Medtronic CD Horizon Spinal System (K091445), specifically the Medtronic SPIRE Spinous Process Plate component.) |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "biomechanical testing" and refers to "ASTM F1717 – Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." This is a laboratory-based biomechanical test, not a clinical study involving human patients. Therefore, the concept of "test set sample size" and "data provenance" in terms of patient data (country of origin, retrospective/prospective) is not applicable here. The samples would be the physical implant constructs tested in the lab. The number of samples tested for each biomechanical scenario is not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This device's clearance is based on mechanical performance compared to a predicate device, not on diagnostic accuracy requiring human expert consensus.
4. Adjudication Method for the Test Set:
Not applicable. As described above, the evaluation is based on biomechanical testing against established ASTM standards and comparison to a predicate device's performance, not on subjective human assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is a spinal implant for fixation, not an image analysis or diagnostic AI device that would typically undergo an MRMC study. The evaluation focuses on physical characteristics and mechanical performance.
6. Standalone (Algorithm Only) Performance:
Not applicable. The "Axle Interspinous Fusion System" is a physical medical device, an implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance is established by the ASTM F1717 standard test methods for spinal implant constructs in a vertebrectomy model and the performance characteristics of the predicate device (Medtronic CD Horizon Spinal System, specifically the Medtronic SPIRE Spinous Process Plate component). The acceptance criteria are that the device's mechanical performance is substantially equivalent to the predicate performance when tested according to these standards.
8. Sample Size for the Training Set:
Not applicable. Since this is a physical medical device and not an AI/machine learning system, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for an AI/machine learning model, the establishment of ground truth for such a set is irrelevant in this context.
§ 888.3050 Spinal interlaminal fixation orthosis.
(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.